CN103055225A - Traditional Chinese medicine for treating drug resistant pulmonary tuberculosis and preparation method of traditional Chinese medicine - Google Patents

Traditional Chinese medicine for treating drug resistant pulmonary tuberculosis and preparation method of traditional Chinese medicine Download PDF

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CN103055225A
CN103055225A CN2012103275505A CN201210327550A CN103055225A CN 103055225 A CN103055225 A CN 103055225A CN 2012103275505 A CN2012103275505 A CN 2012103275505A CN 201210327550 A CN201210327550 A CN 201210327550A CN 103055225 A CN103055225 A CN 103055225A
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radix
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许梅
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CHONGQING XUANNU BIOTECHNOLOGY Co Ltd
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Abstract

The invention provides a novel traditional Chinese medicine composition for treating drug resistant pulmonary tuberculosis. The novel traditional Chinese medicine composition contains radix astragali, ranunculus ternatus, white hyacinth bean, caulis polygoni multiflori, morinda officinalis, eclipta, areca-nuts, radix stemonae, Chinese pulsatilla roots, blackberrykiky rhizome, rhizome anemarrhenae, radix semiaquilegiae, nutmeg, pummel peels, aster, galangal, herba orostachyos, safflower carthamus, salvia miltiorrhiza, cacumen platycladi and leonurus. The traditional Chinese medicine composition provided by the invention has the functions of improving whole function recovery, enhancing immunity of the organism and increasing drug susceptibility and also has the effects of shortening the treatment course, rapidly taking an effect and reducing toxic and side effects as comparison with a western medicine.

Description

Be used for the treatment of Chinese medicine of drug-tolerant pulmonary tuberculosis and preparation method thereof
Technical field
The present invention relates to the Chinese medicine technical field, relate in particular to a kind of Chinese medicine composition that is used for the treatment of drug-tolerant pulmonary tuberculosis.
Background technology
Pulmonary tuberculosis is the chronic infectious disease that the infection by the pulmonary tuberculosis mycobacteria causes, pulmonary tuberculosis discharge of bacteria patient is the social epidemic source, tulase mainly is the disease that causes by respiratory infectious, it is the Infectious Diseases of serious harm human health, being public health and the social problem of global concern, also is one of principal disease of China's priority control.
National tuberculosis epidemiology survey result showed in 2000, and the population of China 45% has infected tulase, about 5.5 hundred million people of number of the infected, now lunger 4,500,000 people.Wherein 1,500,000 people are radiography on infectious pulmonary tuberculosis, and therefore, the control pulmonary tuberculosis becomes outstanding public health problem of China.
To be that tubercule bacillus is many invaded by respiratory tract the reason that pulmonary tuberculosis produces, enter alveolar after, engulfed by macrophage.Macrophage kills and wounds it because the toxic action of the compositions such as thalline lipid, sulfatidate, tubercule bacillus can be escaped, and the nutritional condition that can provide by cell and be able to survival or indomitable breeding in macrophage, causes the dead cracking of phagocyte.The tubercule bacillus that discharges can or be engulfed the repetition said process again in the extracellular breeding again, thereby causes the tuberculosis exudative inflammation.The pulmonary tuberculosis immunologic function disorder relates to cellular immunization, humoral immunization and multiple lymphokine, and the interaction between them and relation are very complicated.The caused immunity infringement of tubercule bacillus is one of important mechanisms of Tuberculosis.
Adopt Western medicine chemotherapy technology can improve the cure rate of pulmonary tuberculosis, reduce mortality rate, but tubercule bacillus is responsive to Western medicine antimycobacterial drugs such as isoniazid, sodium aminosalicylate, streptomycin, rifampicin, easily produce the drug resistance variation.In case produce the original sensitivity to medicine of the extremely difficult recovery of drug resistance.And anti-multiple medicine bacterial strain is increasing, produces drug-tolerant pulmonary tuberculosis, continues to adopt western medicine, and the course for the treatment of is long, and it is slow to take effect.
Usually, the conventional standard Drug therapy of pulmonary tuberculosis, most patients can fully recover, but along with the increasing of irrational drug combination, immunity infringement host, some patients were can not tolerate the chemicals toxicity and be interrupted, interrupt or subtract voluntarily the reason such as medicine, more and more pulmonary tuberculosis patient changes the drug tolerance pulmonary tuberculosis patient into.
Drug-tolerant pulmonary tuberculosis is the difficult problem in the pulmonary tuberculosis control, and cure rate is generally lower, and success rate is less than 70%, and mortality rate is many, has become the difficult problem that pendulum needs to be resolved hurrily in face of medical circle, also day by day becomes the social problem that receives much attention.Modern study proof pulmonary tuberculosis be a kind of take cellular immune function lowly as the disease of feature, generation and the Immune Function of drug tolerance pulmonary tuberculosis are unbalance, especially t lymphocyte subset group's proportional imbalance and dysfunction have substantial connection.
On the other hand, it is many that drug-tolerant pulmonary tuberculosis is treated needed expense, is more than 10 times of common non-drug-tolerant pulmonary tuberculosis mostly, also is a difficult problem concerning patient family.
Chinese medicine thinks that immunity of organisms lowly is not only the main cause of pulmonary tuberculosis recurrence, also is the key point that can drug tolerance pulmonary tuberculosis cure; Because pulmonary tuberculosis focus center blood circulation is obstructed, cause chemicals fully not infiltrate in addition, focus can not be restored, thereby cause the lung tissue damage, respiratory dysfunction has a strong impact on patient health and life.Therefore, improve patient's immunity of organisms, kill tubercule bacillus, promote the circulation of focus peripheral blood, improve chemotherapeutics concentration in the focus, softening and dwindle focus, recover that the lung tissue normal configuration is the cardinal principle of thoroughly curing drug tolerance pulmonary tuberculosis in the focus.
Chinese medicine not only can be treated focal lesion in treatment drug tolerance pulmonary tuberculosis process, eliminate or alleviate the untoward reaction that Western medicine brings, and helping the human righteousness, improve immunity of organisms, blood circulation promoting, softening and dwindle the focus aspect, it has the irreplaceable advantage of chemotherapy.The characteristics that also have simultaneously Shorten the Treatment Process.In addition, for the patient that can not use chemotherapeutics because not tolerating the chemotherapeutics untoward reaction, Chinese medicine can be again it unique treatment approach is provided.
Therefore, the invention provides a kind of novel Chinese medicine composition that is used for the treatment of drug-tolerant pulmonary tuberculosis, adopt this Chinese medicine composition to prepare drug-tolerant pulmonary tuberculosis and have the recovery of the allomeric function of improvement, improve immunity of organisms, strengthen drug susceptibility, it is empty closed to promote focus to inhale, with respect to Western medicine, have to shorten and treat the course for the treatment of, instant effect, the effect of minimizing toxic and side effects.
Summary of the invention
Technical problem to be solved by this invention is, a kind of Chinese medicine composition that is used for the treatment of drug-tolerant pulmonary tuberculosis is provided, it has the allomeric function of improvement and recovers, improve immunity of organisms, strengthen drug susceptibility, with respect to Western medicine, have to shorten and treat the course for the treatment of, instant effect, the effect of minimizing toxic and side effects.
In order to solve the problems of the technologies described above, the invention provides a kind of novel Chinese medicine composition that is used for the treatment of drug-tolerant pulmonary tuberculosis, it comprises the Radix Astragali, Radix Ranunculi Ternati, Semen Lablab Album, Caulis Polygoni Multiflori, Radix Morindae Officinalis, Herba Ecliptae, Semen Arecae, the Radix Stemonae, the Radix Pulsatillae, Rhizoma Belamcandae, the Rhizoma Anemarrhenae, Radix Semiaquilegiae, Semen Myristicae, Exocarpium Citri Grandis, Radix Asteris, Rhizoma Alpiniae Officinarum, Herba Orostachyos, Flos Carthami, Radix Salviae Miltiorrhizae, Cacumen Platycladi, Herba Leonuri.
Wherein, each composition weight umber ratio is in the described Chinese medicine composition: the Radix Astragali 62 ~ 72 weight portions, Radix Ranunculi Ternati 48 ~ 58 weight portions, Semen Lablab Album 36 ~ 46 weight portions, Caulis Polygoni Multiflori 27 ~ 37 weight portions, Radix Morindae Officinalis 31 ~ 41 weight portions, Herba Ecliptae 16 ~ 26 weight portions, Semen Arecae 8 ~ 18 weight portions, the Radix Stemonae 24 ~ 34 weight portions, the Radix Pulsatillae 37 ~ 47 weight portions, Rhizoma Belamcandae 23 ~ 33 weight portions, the Rhizoma Anemarrhenae 32 ~ 42 weight portions, Radix Semiaquilegiae 12 ~ 22 weight portions, Semen Myristicae 18 ~ 28 weight portions, Exocarpium Citri Grandis 21 ~ 31 weight portions, Radix Asteris 14 ~ 24 weight portions, Rhizoma Alpiniae Officinarum 17 ~ 27 weight portions, Herba Orostachyos 22 ~ 32 weight portions, Flos Carthami 26 ~ 36 weight portions, Radix Salviae Miltiorrhizae 30 ~ 40 weight portions, Cacumen Platycladi 16 ~ 26 weight portions, Herba Leonuri 21 ~ 31 weight portions.
Wherein, in the described Chinese medicine composition each composition weight umber than further being: the Radix Astragali 67 ~ 72 weight portions, Radix Ranunculi Ternati 53 ~ 58 weight portions, Semen Lablab Album 41 ~ 46 weight portions, Caulis Polygoni Multiflori 32 ~ 37 weight portions, Radix Morindae Officinalis 36 ~ 41 weight portions, Herba Ecliptae 21 ~ 26 weight portions, Semen Arecae 13 ~ 18 weight portions, the Radix Stemonae 29 ~ 34 weight portions, the Radix Pulsatillae 42 ~ 47 weight portions, Rhizoma Belamcandae 28 ~ 33 weight portions, the Rhizoma Anemarrhenae 37 ~ 42 weight portions, Radix Semiaquilegiae 17 ~ 22 weight portions, Semen Myristicae 23 ~ 28 weight portions, Exocarpium Citri Grandis 26 ~ 31 weight portions, Radix Asteris 19 ~ 24 weight portions, Rhizoma Alpiniae Officinarum 22 ~ 27 weight portions, Herba Orostachyos 27 ~ 32 weight portions, Flos Carthami 31 ~ 36 weight portions, Radix Salviae Miltiorrhizae 35 ~ 40 weight portions, Cacumen Platycladi 21 ~ 26 weight portions, Herba Leonuri 26 ~ 31 weight portions.
Wherein, can further add Cordyceps and Fructus Schisandrae Chinensis in described Chinese medicine composition, described Cordyceps and the addition of described Fructus Schisandrae Chinensis in described Chinese medicine composition are Cordyceps 17 ~ 27 weight portions and Fructus Schisandrae Chinensis 12 ~ 22 weight portions.
Wherein, can further add Radix Curcumae and Rhizoma Corydalis in described Chinese medicine composition, described Radix Curcumae and the addition of described Rhizoma Corydalis in described Chinese medicine composition are Radix Curcumae 21 ~ 31 weight portions and Rhizoma Corydalis 10 ~ 20 weight portions.
Wherein, Chinese medicine composition of the present invention preferably is prepared into powder, oral liquid, tablet, capsule.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and it may further comprise the steps,
The first step, described component is mixed in proportion, is placed in the super micron mill and pulverized 20 minutes～40 minutes, it is in 80%～90% the ethanol that the mixture after pulverizing is dissolved in determining alcohol, reflux, extract, 2 times～4 times, filter, merging filtrate, concentrating under reduced pressure is removed ethanol, obtain dried mastic, wherein, the amount of the ethanol of adding is 2～4 times of first step mixture quality, carries out subsequently drying, pulverized 20 minutes～40 minutes with super micron mill, powder after pulverizing is added water dissolution with respect to 3～5 times of amounts of its quality, stir lower the adding with respect to powder quality 10%～15% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, adding concentration and be 10% sulphuric acid, to regulate pH value be 3～4, static 2～4 hours, filters, filtrate is used alcohol extraction, the extract concentrating under reduced pressure becomes dried mastic, and subsequent drying is ground into 50 orders～100 purpose fine powders;
Second step according to needed dosage form, adds conventional auxiliary element, prepares needed pharmaceutical composition.
Wherein, when the dosage form of described pharmaceutical composition was tablet, described second step was specially:
Add excipient and granulate in the powder of above-mentioned acquisition, drying adds disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or film coating namely obtains tablet.
Wherein, when the dosage form of described pharmaceutical composition was oral liquid, described second step was specially:
In the powder that the first step obtains, add the distilled water with respect to 3～5 times of amounts of its quality, 0.1～0.3 times sucrose, 0.01～0.02 times sodium benzoate stirs, and boils, and cooling is filtered, packing, sterilization namely obtains oral liquid.
Wherein, when the dosage form of described pharmaceutical composition was powder, described second step was specially:
In the powder that the first step obtains, add the starch mix homogeneously with respect to 1～3 times of its quality, be prepared into powder.
The present invention also provides above-mentioned Chinese medicine composition for the preparation of the application in the medicine for the treatment of drug-tolerant pulmonary tuberculosis.
Beneficial effect of the present invention:
Chinese medicine composition provided by the invention has the recovery of the allomeric function of improvement, improves immunity of organisms, strengthens drug susceptibility, with respect to Western medicine, has to shorten and treats the course for the treatment of, instant effect, the effect of minimizing toxic and side effects.
The specific embodiment
Drug-tolerant pulmonary tuberculosis is difficult to cure, and the toxicity of Chemotherapy also causes Liver and kidney, spleen and stomach function infringement, and with at the most viscera YIN sun, disorder of QI and blood, body's immunity reduces, the more difficult recovery of the state of an illness.Chinese medicine and western medicine is thought, drug-tolerant pulmonary tuberculosis belongs to Chinese medicine " pulmonary tuberculosis " category, pulmonary tuberculosis is because the consumptive disease worm corrodes the lobe of the lung, cause a kind of communicable chronic weak property disease that has, because of consumptive disease worm invasion lung system, deficiency of vital QI and falling ill, the sick position of primary disease is at lung, pathologic feature generally has the cloudy two cards that lose of yin asthenia generating intrinsic heat, gas in various degree simultaneously take the deficiency of YIN as main.
Traditional Chinese medical science cognition is also treated drug-tolerant pulmonary tuberculosis and do not deviate from parasite killing tonify deficiency category, and the paathogenic factor of drug-tolerant pulmonary tuberculosis mainly contains two aspects: one is infected by tuberculomyces, and one is deficiency of vital QI.Two kinds of causes of disease of consumptive disease worm and deficiency of vital QI, can be mutually each other because of.The drug-tolerant pulmonary tuberculosis pathogenic factor mainly is the smart Tianjin of energy and blood of human body interior-deficiency, and it is disease that the consumptive disease worm attacks into, sense in an opponent's defence.Because the consumptive disease worm sucks from mouth and nose, directly corrodes lungs, the symptom of lung system such as dry cough, spitting of blood can occur.The drug-tolerant pulmonary tuberculosis course of disease is slow, and infection is arranged, and is many owing to impairment caused by overstrain healthy energy, vital QI cannot conquer pathogen, and experience due to the consumptive disease worm.It is in the majority that its pathology is in the nature the deficiency of YIN, so " the consumptive disease master deficiency of YIN, deficiency of YIN person in eight or nine cases out of ten " arranged.Deficiency of YIN lung-heat is the basic pathogenesis of primary disease, protracted inflammation with the passing of time, deficiency of YIN affecting YANG, vigour consume, negative and positive two are lost, it is deficient not only at lung, then involves for a long time the spleen kidney.
All natural endowments are weak, and daily life is careless, and it is angry to be worried, the wine and women-sensual pursuits overstrain, and wasting QI-blood body fluid, healthy energy is hindered first, and body void is not multiple, and then the consumptive disease worm takes advantage of void and attacks the people, is felt as disease.Visible volume void is the basic immanent cause of drug-tolerant pulmonary tuberculosis morbidity, and deficiency syndrome should be treated by tonifying method is Zhi Qiben so.Chinese medicine not only can the deactivation tubercule bacillus, and has no side effect.Therefore its researching value of Therapeutic Method of this parasite killing of Chinese medicine is very high.
Said as " the medical science main story labor utmost point ": " parasite killing first, so that it is basic absolutely, tonify deficiency first is with multiple its true strength." tonify deficiency, multiple its true strength, parasite killing, absolutely its old complaint.Differentiate what is primary from what is secondary according to physical strength, but especially need to pay attention to invigorating deficiency and tonifying vital QI, strengthen healthy energy, to improve resistance against diseases.Transfer and mend the internal organs emphasis at lung, and should note the internal organs whole relation, simultaneously invigorating spleen and kidney.The tonify deficiency of drug-tolerant pulmonary tuberculosis mainly is that nourishing YIN is empty, take YIN nourishing as main.
Therefore, the present invention is take invigorating deficiency and tonifying vital QI, anti-consumptive disease parasite killing, dissipating blood stasis tissue regeneration promoting as the Therapeutic Principle, a kind of novel Chinese medicine composition that is used for the treatment of drug tolerance pulmonary tuberculosis is provided, and it comprises the Radix Astragali, Radix Ranunculi Ternati, Semen Lablab Album, Caulis Polygoni Multiflori, Radix Morindae Officinalis, Herba Ecliptae, Semen Arecae, the Radix Stemonae, the Radix Pulsatillae, Rhizoma Belamcandae, the Rhizoma Anemarrhenae, Radix Semiaquilegiae, Semen Myristicae, Exocarpium Citri Grandis, Radix Asteris, Rhizoma Alpiniae Officinarum, Herba Orostachyos, Flos Carthami, Radix Salviae Miltiorrhizae, Cacumen Platycladi, Herba Leonuri.
In the side, the Radix Astragali, Semen Lablab Album, Caulis Polygoni Multiflori, Radix Morindae Officinalis, Herba Ecliptae can be improved the lymphocyte phagocytic function, enhancing antibody produces, effect with invigorating deficiency and tonifying vital QI, Radix Ranunculi Ternati, the Radix Stemonae, the Radix Pulsatillae, Rhizoma Belamcandae, the Rhizoma Anemarrhenae, Radix Semiaquilegiae have the effect of heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, Galla Chinensis, Exocarpium Citri Grandis, Radix Asteris, Rhizoma Alpiniae Officinarum have the effect of the pathogenic fire reducing of astringing the lung, relieving diarrhea with astringents, Herba Orostachyos, Flos Carthami, Radix Salviae Miltiorrhizae, Cacumen Platycladi, Herba Leonuri astringing to arrest bleeding, the effect of tonifying the lung granulation promoting.
Each composition weight umber ratio is in the described Chinese medicine composition:
The Radix Astragali 62 ~ 72 weight portions, Radix Ranunculi Ternati 48 ~ 58 weight portions, Semen Lablab Album 36 ~ 46 weight portions, Caulis Polygoni Multiflori 27 ~ 37 weight portions, Radix Morindae Officinalis 31 ~ 41 weight portions, Herba Ecliptae 16 ~ 26 weight portions, Semen Arecae 8 ~ 18 weight portions, the Radix Stemonae 24 ~ 34 weight portions, the Radix Pulsatillae 37 ~ 47 weight portions, Rhizoma Belamcandae 23 ~ 33 weight portions, the Rhizoma Anemarrhenae 32 ~ 42 weight portions, Radix Semiaquilegiae 12 ~ 22 weight portions, Semen Myristicae 18 ~ 28 weight portions, Exocarpium Citri Grandis 21 ~ 31 weight portions, Radix Asteris 14 ~ 24 weight portions, Rhizoma Alpiniae Officinarum 17 ~ 27 weight portions, Herba Orostachyos 22 ~ 32 weight portions, Flos Carthami 26 ~ 36 weight portions, Radix Salviae Miltiorrhizae 30 ~ 40 weight portions, Cacumen Platycladi 16 ~ 26 weight portions, Herba Leonuri 21 ~ 31 weight portions.
Each composition weight umber is than further being in the described Chinese medicine composition:
The Radix Astragali 67 ~ 72 weight portions, Radix Ranunculi Ternati 53 ~ 58 weight portions, Semen Lablab Album 41 ~ 46 weight portions, Caulis Polygoni Multiflori 32 ~ 37 weight portions, Radix Morindae Officinalis 36 ~ 41 weight portions, Herba Ecliptae 21 ~ 26 weight portions, Semen Arecae 13 ~ 18 weight portions, the Radix Stemonae 29 ~ 34 weight portions, the Radix Pulsatillae 42 ~ 47 weight portions, Rhizoma Belamcandae 28 ~ 33 weight portions, the Rhizoma Anemarrhenae 37 ~ 42 weight portions, Radix Semiaquilegiae 17 ~ 22 weight portions, Semen Myristicae 23 ~ 28 weight portions, Exocarpium Citri Grandis 26 ~ 31 weight portions, Radix Asteris 19 ~ 24 weight portions, Rhizoma Alpiniae Officinarum 22 ~ 27 weight portions, Herba Orostachyos 27 ~ 32 weight portions, Flos Carthami 31 ~ 36 weight portions, Radix Salviae Miltiorrhizae 35 ~ 40 weight portions, Cacumen Platycladi 21 ~ 26 weight portions, Herba Leonuri 26 ~ 31 weight portions.
Patient for asthma, can in described Chinese medicine composition, further add Cordyceps and Fructus Schisandrae Chinensis, described Cordyceps and the addition of described Fructus Schisandrae Chinensis in described Chinese medicine composition are Cordyceps 17 ~ 27 weight portions and Fructus Schisandrae Chinensis 12 ~ 22 weight portions, more preferably Cordyceps 22 ~ 27 weight portions and Fructus Schisandrae Chinensis 17 ~ 22 weight portions.
Patient for chest pain, can in described Chinese medicine composition, further add Radix Curcumae and Rhizoma Corydalis, described Radix Curcumae and the addition of described Rhizoma Corydalis in described Chinese medicine composition are Radix Curcumae 21 ~ 31 weight portions and Rhizoma Corydalis 10 ~ 20 weight portions, more preferably Radix Curcumae 26 ~ 31 weight portions and Rhizoma Corydalis 15 ~ 20 weight portions.
The pharmacology of each component is as follows in the described Chinese medicine:
The Radix Astragali: bitter in the mouth, cold in nature, GUIXIN, lung, stomach, gallbladder, large intestine channel have tonifying Qi and lifting yang, and benefit is defended consolidating superficial resistance, promoting pus discharge and tissue regeneration strengthening, the effect of inducing diuresis to remove edema cures mainly diarrhoea, dysentery, jaundice, pyretic stranguria due to damp and hot; The cough due to lung-heat, thirsty pharyngalgia also can be used for excessive fetal movement due to heat in pregnancy, and the pyretic toxicity pathogenic fire is invaded the swollen card of carbuncle sore poison of excessive skin, Radix Astragali merit.Non-specific and specific cellular immunity has potentiation to body for it, can improve the T ability of cell proliferation, promote macrophage activation, the Radix Astragali can end night sweat, accelerates focus absorption and cavity healing, improve sputum negative conversion rate, and the toxic and side effects of Antituberculous Drugs has obvious antagonism.
Radix Ranunculi Ternati: sweet in the mouth, suffering, slightly warm in nature is returned liver, lung meridian, has dissipating phlegm and resolving masses, and the effect of removing toxic substances and promoting subsidence of swelling cures mainly the scrofula sucutaneous nodule, furuncle, worm venom, migraine, malaria, toothache.Pulmonary tuberculosis, tuberculous lymphadenitis, lymphadenitis, the cards such as pharyngolaryngitis, but the killing activity of the ranunculus ternatus lactone enhancing body cytotoxic T cell that contains in the Radix Ranunculi Ternati reach the purpose of anti-drug resistance Mycobacterium tuberculosis.
Semen Lablab Album: sweet in the mouth, slightly warm in nature, enter spleen, stomach warp, have invigorating the spleen for eliminating dampness and in the effect of relieving summer heat, be used for the cards such as indigestion and loss of appetite abdominal distention, loose stool, aqueous-grainy diarrhea, the vomiting of feeling sick of weakness of the spleen and stomach.
Caulis Polygoni Multiflori: sweet in the mouth, little hardship, property is flat; GUIXIN, Liver Channel have the effect of energy tranquilizing by nourishing the heart, dispelling wind and removing obstruction in the collateral, cure mainly insomnia and dreamful sleep, blood deficiency general pain, numbness of the skin, rheumatic arthralgia, the cards such as wind skin ulcer scabies.
Radix Morindae Officinalis: acrid in the mouth, sweet, slightly warm in nature enters liver, kidney channel, has the effect of kidney-replenishing, bone and muscle strengthening, wind-damp dispelling, is used for impotence due to deficiency of the kidney, seminal emission premature ejaculation, few abdomen cold type of pain, and cold womb is infertile, the cards such as the muscles and bones flaccidity due to the deficiency of the liver and kindey is soft, chills and pain of the waist and kness.
Herba Ecliptae: sweet in the mouth, acid, cold in nature, return liver, kidney channel, play not liver and kidney tonifying, the effect of cooling blood for hemostasis is used for having a dizzy spell due to the hepatic and renal YIN deficiency, blurring of vision, soreness of the waist and knees; Being suitable for the deficiency of YIN has hot person, is used for the treatment of the haematemesis of accumulated heat in the stomach, the cards such as the hemoptysis of injury of blood vessel of the lung by heat.
Semen Arecae: bitter in the mouth, suffering, warm in nature, return stomach, large intestine channel, have parasite killing, removing food stagnancy, circulation of qi promoting, diuretic, the effect of preventing the attack (or recurrence) of malaria cures mainly abdominal pain due to worm stagnation, stagnant dysentery, tenesmus, edema beriberi, the cards such as malaria.
The Radix Stemonae: sweet in the mouth, hardship, slightly warm in nature is returned lung meridian, has nourishing the lung to keep the adverse QI downward cough-relieving, and the effect of parasite killing cures mainly new chronic cough and coughs, pulmonary tuberculosis cough, pertussis; Outer head louse, body louse, enterobiasis, the cards such as pudendum Pruritus of being used for.
The Radix Pulsatillae: bitter in the mouth, cold in nature, enter stomach, large intestine channel, have heat-clearing and toxic substances removing, the effect of eliminating pathogenic heat from blood to cure dysentery, being mainly used in gastrointestinal has damp and hot stagnant heating stomachache, dysentery pus and blood, the cards such as tenesmus.
Rhizoma Belamcandae: bitter in the mouth, cold in nature, return lung, Liver Channel, have heat-clearing and toxic substances removing, the effect of clearing away phlegm sore-throat relieving is used for the pent-up of pyretic toxicity phlegm-fire, laryngopharynx swelling and pain, accumulation and obstruction of sputum, the cards such as cough and asthma.
The Rhizoma Anemarrhenae: bitter in the mouth, sweet, cold in nature, enter lung, stomach, kidney channel, the relieving restlessness of purging heat is arranged, the effect of nourshing Yin and drynsessmoistening prescription, clearing away lung-heat to relieve cough cures mainly fever caused by exogenous pathogenic factors, and high heat is irritated, lung-heat type cough, the interior-heat symptom such as quench one's thirst; Its bitter cold matter profit, the property sedimentation can heat clearing away, can promote the production of body fluid again, kindly controls warm pathogenic factor and enters edema caused by disorder of QI, the intenseness of heat impairment of body fluid; Also be used for the treatment of diabetes; Phlegm-heat obstructing in the lung and breathing heavily, the xeropulmonary cough, expectorant is few unfavorable; Hyperactivity of fire caused by deficiency of YIN, the symptoms such as hyperactivity of deficient fire.
Radix Semiaquilegiae: sweet in the mouth, little hardship, little suffering, cold in nature, return liver, spleen, urinary bladder channel, have heat-clearing and toxic substances removing; Dispersing swelling and dissipating binds; The effect of relieving stranguria by diuresis.It is frightened to cure mainly children's's heat; Epilepsy; Carbuncle; Furuncle; Acute mastitis; Scrofula; The skin itching sore; Conjunctival congestion and swelling pain; Pharyngalgia; Snake bite and insect sting; Pyretic stranguria; The cards such as sand Stranguria.
Semen Myristicae: acrid in the mouth, hardship, warm in nature, enter spleen, stomach, large intestine channel, have the effect of warming middle-JIAO astringing intestine to stop diarrhea, promote qi circulation digestion promoting, be used for diarrhea of deficiency type, cold-dysentery, abdominal distention, lack of appetite vomiting, the dyspepsia card such as do not disappear.
Exocarpium Citri Grandis: acrid in the mouth, hardship, warm in nature.Return lung, spleen channel, have cold expelling, dampness, promoting the circulation of QI, the effect of expectorant.Be used for the cards such as cough due to wind and cold, itching of the throat abundant expectoration, food stagnation get sick from drinking too much wine, the jailbird is vexed.
Radix Asteris: bitter in the mouth, sweet, slightly warm in nature enters lung meridian, have dredging lung meridian QI and blood, nourishing the lung to keep the adverse QI downward, the effect of relieving cough and resolving phlegm is mainly used in various cough with dyspnea, expectoration is not well, the cards such as sputum mixed with blood, the cough with dyspnea of especially applicable lung qi stasis, the visitor prevents and treats the hemoptysis vomiting pus of lung abscess, exogenous cough, no matter wind and cold wind heat, all applicable, Radix Asteris can increase bronchial secretion, in order to expectoration, and the effect of antitussive is arranged.
Rhizoma Alpiniae Officinarum: acrid in the mouth, hot in nature, return spleen, stomach warp, have warming stomach for dispelling cold, the effect of the pain relieving that helps digestion.Be used for coldness and pain in the epigastrium, gastrofrigid vomiting, the cards such as belch acid regurgitation.
Herba Orostachyos: sour in the mouth, hardship, cool in nature, enter liver, lung two warps, have heat-clearing and toxic substances removing, hemostasis, dampness removing, the effect of detumescence cures mainly haematemesis, epistaxis, dysentery, hepatitis, malaria, pyretic stranguria, hemorrhoid, eczema, carbuncle poison, furuncle, the soup fire card such as burn.
Flos Carthami: warm in nature, acrid in the mouth enters, the heart, Liver Channel, has promoting blood circulation to restore menstrual flow, and the effect of stasis-dispelling and pain-killing is used for amenorrhea, dysmenorrhea, lochia, lump in the abdomen mass in the abdomen, injury from falling down, the skin infection disease such as swell and ache.
Radix Salviae Miltiorrhizae: bitter in the mouth, cold nature, GUIXIN, Liver Channel have promoting blood flow to regulate menstruation, stasis-dispelling and pain-killing, the removing heat from blood eliminating carbuncle, the relieving restlessness that clears away heart-fire, the effect of nourishing blood to tranquillize the mind cures mainly menoxenia, the amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, the cards such as angina pectoris.
Cacumen Platycladi: bitter in the mouth, puckery, cold in nature, enter the heart, liver, large intestine channel, have cooling blood for hemostasis, wind-damp dispelling, the effect of loose toxic swelling cures mainly haematemesis, epistaxis, hematuria, dysentery, hemorrhoidal hamorrhage, metrorrhagia, rheumatic arthralgia, bacillary dysentery, hypertension, cough, erysipelas, mumps, the cards such as scald.
Herba Leonuri: bitter in the mouth, suffering, cold nature enters liver, pericardium channel, has promoting blood flow to regulate menstruation, and the effect of inducing diuresis to remove edema cures mainly menoxenia, dysmenorrhea, amenorrhea, lochiorrhea, edema oliguria, the cards such as acute nephritis edema.
Cordyceps: sweet in the mouth, property is flat, enters lung, kidney channel, has kidney invigorating and YANG supporting, tonifying the lung is relievingd asthma, and the effect of hemostasis and phlegm, the traditional Chinese medical science think that Cordyceps enters lung kidney two warps, can tonifying the lung cloudy, again can kidney-replenishing, cure mainly and suffer from a deficiency of the kidney, impotence and seminal emission, soreness of waist and knee joint, weak after being ill, chronic cough is weak, phthisical cough expectorant blood, spontaneous sweatings etc. are unique a kind of simultaneously balance, the Chinese medicine composition of adjusting negative and positive, cure mainly senile chronic bronchitis, emphysema, pulmonary tuberculosis, bronchial asthma, cough is breathed hard, the dyspnea due to deficiency spitting of blood; The empty hyperhidrosis of body, spontaneous perspiration, night sweat; Weak after being ill, prolonged deficiency is not multiple, or the labor that declines is weak, and various chronic expendable; Deficiency of kidney-QI, soreness of waist and knee joint, impotence and seminal emission; Cancer; The diabetes patient, lupus erythematosus, the cards such as chronic nephritis and aplastic anemia and leukopenia.
Fructus Schisandrae Chinensis: warm in nature, sour in the mouth, sweet is returned lung, the heart, kidney channel, have the convergence astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, the effect of kidney calming, cure mainly the chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Tianjin wound is thirsty, the deficient pulse of losing heart, interior-heat is quenched one's thirst, the cards such as palpitation and insomnia.
Radix Curcumae: acrid in the mouth, hardship, cold in nature, return liver, the heart, lung meridian, have promoting blood circulation and stopping pain, promoting QI circulation for relieving depression, the removing heat from blood that clears away heart-fire, the effect of promoting the function of the gallbladder to alleviate jaundice cures mainly the amenorrhea dysmenorrhea, chest and abdomen swelling and pain, twinge, the calentura coma, epilepsy is gone mad, the cards such as jaundice dark coloured urine.
Rhizoma Corydalis: have another name called corydalis tuber, rhizoma corydalis, Rhizoma Corydalis, acrid in the mouth, hardship, warm in nature, enter liver, spleen channel, have promoting blood circulation to remove blood stasis, the effect of promoting the circulation of QI to relieve pain is used for the various pain cards that qi depression to blood stasis causes, particularly trusted subordinate's pain is commonly used, such as depressed liver and heat transmission, the gastral cavilty abdominal distention of incoordination between the liver and stomach has the analgesic effect.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and it may further comprise the steps,
The first step, described component is mixed in proportion, is placed in the super micron mill and pulverized 20 minutes～40 minutes, it is in 80%～90% the ethanol that the mixture after pulverizing is dissolved in determining alcohol, reflux, extract, 2 times～4 times, filter, merging filtrate, concentrating under reduced pressure is removed ethanol, obtain dried mastic, wherein, the amount of the ethanol of adding is 2～4 times of first step mixture quality, carries out subsequently drying, pulverized 20 minutes～40 minutes with super micron mill, powder after pulverizing is added water dissolution with respect to 3～5 times of amounts of its quality, stir lower the adding with respect to powder quality 10%～15% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, adding concentration and be 10% sulphuric acid, to regulate pH value be 3～4, static 2～4 hours, filters, filtrate is used alcohol extraction, the extract concentrating under reduced pressure becomes dried mastic, and subsequent drying is ground into 50 orders～100 purpose fine powders;
Second step according to needed dosage form, adds conventional auxiliary element, prepares needed pharmaceutical composition.
Chinese medicine composition of the present invention preferably is prepared into powder, oral liquid, tablet, capsule.
When the dosage form of described pharmaceutical composition was tablet, described second step was specially:
Add excipient and granulate in the powder of above-mentioned acquisition, drying adds disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or film coating namely obtains tablet.
Wherein, excipient is starch and derivant, dextrin, carboxymethyl starch, calcium hydrogen phosphate and other pharmaceutic adjuvants; Described disintegrating agent is sodium carboxymethyl cellulose, hypromellose and pharmaceutic adjuvant with water swelling; Described lubricant is the pharmaceutic adjuvant of Polyethylene Glycol, magnesium stearate, Pulvis Talci and tool lubrication; Described sugar coating material is sucrose, Pulvis Talci, gelatin, pigment, river wax etc.; Described thin film coating material is the water of stomach dissolution type, pure molten coating material.Wherein excipient, disintegrating agent, lubricant, sugar coating, the weight content of film coating material in medicine are respectively: 5～70%, 1～30%, 0.1～10%, 35～90%, 1.5～5%.
When the dosage form of described pharmaceutical composition was oral liquid, described second step was specially:
In the powder that the first step obtains, add the distilled water with respect to 3～5 times of amounts of its quality, 0.1～0.3 times sucrose, 0.01～0.02 times sodium benzoate stirs, and boils, and cooling is filtered, packing, sterilization namely obtains oral liquid.
When the dosage form of described pharmaceutical composition was powder, described second step was specially:
In the powder that the first step obtains, add the starch mix homogeneously with respect to 1～3 times of its quality, be prepared into powder.
The present invention also provides above-mentioned Chinese medicine composition for the preparation of the application in the medicine for the treatment of drug-tolerant pulmonary tuberculosis.
Below adopt embodiment to describe embodiments of the present invention in detail, how the application technology means solve technical problem to the present invention whereby, and the implementation procedure of reaching technique effect can fully understand and implements according to this.
The powder 1 of embodiment 1 the present invention preparation
With Radix Astragali 67g, Radix Ranunculi Ternati 53g, Semen Lablab Album 41g, Caulis Polygoni Multiflori 32g, Radix Morindae Officinalis 36g, Herba Ecliptae 21g, Semen Arecae 13g, Radix Stemonae 29g, Radix Pulsatillae 42g, Rhizoma Belamcandae 28g, Rhizoma Anemarrhenae 37g, Radix Semiaquilegiae 17g, Semen Myristicae 23g, Exocarpium Citri Grandis 26g, Radix Asteris 19g, Rhizoma Alpiniae Officinarum 22g, Herba Orostachyos 27g, Flos Carthami 31g, Radix Salviae Miltiorrhizae 35g, Cacumen Platycladi 21g, Herba Leonuri 26g mixes, be placed in the super micron mill and pulverized 30 minutes, it is in 90% the ethanol that mixture after pulverizing is dissolved in the 2000g determining alcohol, reflux, extract, 3 times, filter, merging filtrate, concentrating under reduced pressure is removed ethanol, obtain dried mastic, carry out subsequently drying, pulverized 40 minutes with super micron mill, the water dissolution that powder after pulverizing is added 2600g, stir the lower 65g of adding sodium hydroxide hydrotropy, regulating pH value is 7, filter, adding concentration and be 10% sulphuric acid, to regulate pH value be 4, static 4 hours, filter, filtrate is used alcohol extraction, the extract concentrating under reduced pressure becomes dried mastic, and subsequent drying is ground into 100 purpose fine powders, starch mix homogeneously with 1300g is prepared into powder 1.
Acute toxicity test
Powder 1 with present embodiment 1 preparation is dissolved in the distilled water, gives white mice feeding dispensing with 200 times of clinical consumption per day, observes 5.All white mice are strong as a result deposits, and its activity, diet, hair, Excreta are no abnormal, have no toxic reaction.Irritation test is carried out in white mouse oral cavity and damaged skin, there are no irritative response and other untoward reaction.
Long term toxicity test
With 1 pair of mice of powder of embodiment 1 preparation by 7.81,18.34 and 40.11g crude drug/kg be dissolved in the water, 12 weeks of continuous use, every day 2 times, and after 3 weeks of drug withdrawal, the result shows: Chinese medicine of the present invention all has no significant effect indexs such as the hair of rat, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat, the internal organs naked eyes do not find that difference changes and the histological examination result shows, after 12 weeks of medication and 3 weeks of drug withdrawal, each internal organs of rat are all without obviously changing.Illustrate that toxicity is little after Chinese medicine of the present invention is to the rat long-term prescription, also do not have the difference reaction after the drug withdrawal, application safety.
The powder 2 of embodiment 2 the present invention preparation
With Radix Astragali 70g, Radix Ranunculi Ternati 56g, Semen Lablab Album 43g, Caulis Polygoni Multiflori 35g, Radix Morindae Officinalis 38g, Herba Ecliptae 23g, Semen Arecae 16g, Radix Stemonae 31g, Radix Pulsatillae 45g, Rhizoma Belamcandae 31g, Rhizoma Anemarrhenae 41g, Radix Semiaquilegiae 17g, Semen Myristicae 26g, Exocarpium Citri Grandis 30g, Radix Asteris 21g, Rhizoma Alpiniae Officinarum 25g, Herba Orostachyos 31g, Flos Carthami 31g, Radix Salviae Miltiorrhizae 36g, Cacumen Platycladi 24g, Herba Leonuri 30g mixes, be placed in the super micron mill and pulverized 30 minutes, it is in 90% the ethanol that mixture after pulverizing is dissolved in the 2000g determining alcohol, reflux, extract, 3 times, filter, merging filtrate, concentrating under reduced pressure is removed ethanol, obtain dried mastic, carry out subsequently drying, pulverized 40 minutes with super micron mill, the water dissolution that powder after pulverizing is added 2600g, stir the lower 65g of adding sodium hydroxide hydrotropy, regulating pH value is 7, filter, adding concentration and be 10% sulphuric acid, to regulate pH value be 4, static 4 hours, filter, filtrate is used alcohol extraction, the extract concentrating under reduced pressure becomes dried mastic, and subsequent drying is ground into 100 purpose fine powders, starch mix homogeneously with 1300g is prepared into powder 2.
The tablet 1 of embodiment 3 the present invention preparation
With Radix Astragali 67g, Radix Ranunculi Ternati 53g, Semen Lablab Album 41g, Caulis Polygoni Multiflori 32g, Radix Morindae Officinalis 36g, Herba Ecliptae 21g, Semen Arecae 13g, Radix Stemonae 29g, Radix Pulsatillae 42g, Rhizoma Belamcandae 28g, Rhizoma Anemarrhenae 37g, Radix Semiaquilegiae 17g, Semen Myristicae 23g, Exocarpium Citri Grandis 26g, Radix Asteris 19g, Rhizoma Alpiniae Officinarum 22g, Herba Orostachyos 27g, Flos Carthami 31g, Radix Salviae Miltiorrhizae 35g, Cacumen Platycladi 21g, Herba Leonuri 26g mixes, be placed in the super micron mill and pulverized 30 minutes, it is in 90% the ethanol that mixture after pulverizing is dissolved in the 2000g determining alcohol, reflux, extract, 3 times, filter, merging filtrate, concentrating under reduced pressure is removed ethanol, obtain dried mastic, carry out subsequently drying, pulverized 40 minutes with super micron mill, the water dissolution that powder after pulverizing is added 2600g, stir the lower 65g of adding sodium hydroxide hydrotropy, regulating pH value is 7, filter, adding concentration and be 10% sulphuric acid, to regulate pH value be 4, static 4 hours, to filter, filtrate is used alcohol extraction, the extract concentrating under reduced pressure becomes dried mastic, subsequent drying is ground into 100 purpose fine powders, adds 800g starch and granulate in above-mentioned fine powder, dry, add subsequently the 15g sodium carboxymethyl cellulose, the 2g magnesium stearate, tabletting, the tablet 1 of system.
The tablet 2 of embodiment 4 the present invention preparation
With Radix Astragali 72g, Radix Ranunculi Ternati 58g, Semen Lablab Album 43g, Caulis Polygoni Multiflori 36g, Radix Morindae Officinalis 36g, Herba Ecliptae 21g, Semen Arecae 14g, Radix Stemonae 30g, Radix Pulsatillae 44g, Rhizoma Belamcandae 31g, Rhizoma Anemarrhenae 37g, Radix Semiaquilegiae 18g, Semen Myristicae 23g, Exocarpium Citri Grandis 30g, Radix Asteris 21g, Rhizoma Alpiniae Officinarum 24g, Herba Orostachyos 30g, Flos Carthami 35g, Radix Salviae Miltiorrhizae 35g, Cacumen Platycladi 21g, Herba Leonuri 27g mixes, be placed in the super micron mill and pulverized 30 minutes, it is in 90% the ethanol that mixture after pulverizing is dissolved in the 2000g determining alcohol, reflux, extract, 3 times, filter, merging filtrate, concentrating under reduced pressure is removed ethanol, obtain dried mastic, carry out subsequently drying, pulverized 40 minutes with super micron mill, the water dissolution that powder after pulverizing is added 2600g, stir the lower 65g of adding sodium hydroxide hydrotropy, regulating pH value is 7, filter, adding concentration and be 10% sulphuric acid, to regulate pH value be 4, static 4 hours, to filter, filtrate is used alcohol extraction, the extract concentrating under reduced pressure becomes dried mastic, subsequent drying is ground into 100 purpose fine powders, adds 800g starch and granulate in above-mentioned fine powder, dry, add subsequently the 15g sodium carboxymethyl cellulose, the 2g magnesium stearate, tabletting, the tablet 2 of system.
Embodiment 5 clinical experiments
Case is selected
Select before the hospitalization acid-fast stain of expectorant smear or cultivate positive, drug-tolerant pulmonary tuberculosis patient's 280 examples, male 153 examples, women 127 examples, 35～83 years old age, average (38 ± 3.5) year.Carry out random packet: treatment group 180 examples, male 92 examples, women 78 examples, year mean age (36 ± 5.2); Matched group 100 examples, male 63 examples, women 37 examples, year mean age (41 ± 3.8).
Two groups of patients' age, state of an illness difference not statistically significant before treatment.Normal health 40 people, male 25 people, women 15 people, year mean age (27 ± 3.8).
Check and determination methods
Expectorant mycobacterium tuberculosis smear adopts the RAS inspection; The expectorant mycobacterium tuberculosis is cultivated and drug sensitive test adopts Bact/Alert 3D culture machine produced in USA to carry out expectorant cultivation and drug sensitive test; Erythrocyte sedimentation rate adopts the conventional method inspection; The Double spiral CT conventional sweep is adopted in breast examination, and focus absorbs that the criterion that takes a turn for the better is that extent of disease diminishes, the cavity diminishes 30% or more or closed, focus density increase or the calcification phenomenon is arranged.Immunologic test adopts flow cytometer to detect peripheral blood T cells subgroup (CD 3, CD 4, CD 8) variation.
Statistical procedures
Treat the detection data of the routine number of forward and backward improvement and amynologic index, all after the SPSS11.5 statistical software carried out statistical procedures, P＜0.05 was for having statistical significance, P〉0.05 not statistically significant.
Therapeutic scheme
Two groups of patients give 3HREZ (S)/6HRE, or adjust therapeutic regimen according to the drug sensitive test result, protect the liver in right amount auxiliary treatment simultaneously.The drug resistance patient refers to treat unsuccessfully for the first time, sun, irregular chemotherapy surpass 1 month patient to the regular medication full course for the treatment of of expectorant bacterium again again.Drug resistance refers to the two or more medicine in anti-at least isoniazid, rosickyite .gamma.-pyridinecarboxylic acid, the levofloxacin.
Matched group take anti-isoniazid, rosickyite .gamma.-pyridinecarboxylic acid, three kinds of medicines of levofloxacin as the direct inspection on basis under chemotherapy regimen, 2 months courses for the treatment of, treatment group be under the basic direct inspection under the chemotherapy regimen except implementing anti-isoniazid, rosickyite .gamma.-pyridinecarboxylic acid, three kinds of medicines of levofloxacin, take simultaneously the powder 1 of oral embodiment 1 preparation, each with 100g powder heating for dissolving in the water of 500g, every day 3 times, at every turn at twice administration, 2 months courses for the treatment of.
X-ray checks
Take the photograph positive lateral chest film before the treatment 1 time, check per month rabat in the treatment 1 time, every month, the row lung CT was unenhanced 1 time.Criterion: extent of disease after with all focus additions shared lung field number calculate.Focus: absorb fully: focus absorbs fully; Obviously absorb: focus absorption 〉=former focus diameter 1/2; Absorb: focus absorption＜former focus diameter 1/2; Without changing: focus is without the changer; Worsen: pathological changes increases or new pathological changes person occurs.Cavity: closure: the cavity is closed or block closed; Dwindle: the cavity dwindles＞former empty diameter 1/2; Constant: the cavity dwindles or increases＜former empty diameter 1/2; Increase: cavity increase＞former empty diameter 1/2.Comprehensive therapeutic effect standard according to nineteen eighty-two national tuberculosis control academic conference formulation.
The result
The clinical indices testing result
After treatment 1 month, treatment group expectorant bacterium smear and expectorant cultivation the moon turn, focus absorbs improvement, erythrocyte sedimentation rate recovers normal and the matched group comparing difference has statistical significance (P＜0.05), sees table 1 for details.
The treatment of table 1 indices is improvement routine number (%) after 2 months
Group n Sputum conversion Expectorant is cultivated the moon and is turned It is normal that erythrocyte sedimentation rate recovers Rabat absorbs and takes a turn for the better
Treatment group 180 153(85%) 150(83.3%) 156(86.7%) 161(89.4%)
Matched group 100 23(23%) 19(19%) 31(31%) 29(29%)
P 0.05 0.05` 0.05 0.05
Flow cytometer detects the result of T cell subsets
(1) treatment group and matched group be before treatment, peripheral blood T cells subgroup difference not statistically significant (P〉0.05), with the normal group comparing difference statistical significance (P＜0.05) is arranged, see Table 2.
Table 2 treatment front two groups of T cell subsets testing results (%)
Group n Treatment group Matched group Normal group
CD 3 180 0.45±0.02 0.43±0.08 0.75±0.03
CD 4 100 0.34±0.04 0.35±0.06 0.55±0.05
CD 8 40 0.29±0.08 0.28±0.03 0.24±0.03
(2) testing result for the treatment of t lymphocyte subsets of peripheral blood after 2 months is learned the t check by statistics, and treatment group is CD after 2 months 3, CD 4, CD 8Level all takes an evident turn for the better before the treatment, and difference has statistical significance (t=4.24; P＜0.05); Matched group after 2 months the T cell subsets have no and be clearly better (t=1.23, P〉0.05), see Table 3.
Table 3 treatment two groups of T cell subsets testing results (%) after 2 months
Group n Treatment group Matched group Normal group
CD 3 180 0.50±0.07 0.45±0.03 0.75±0.03
CD 4 100 0.41±0.06 0.37±0.05 0.55±0.05
CD 8 40 0.25±0.02 0.26±0.07 0.24±0.03
Pulmonary condition changes
2 months pathological changes absorbing state for the treatment of group and matched group compares (%), the results are shown in Table 4.
2 months pathological changes absorbing state of table 4 treatment group and matched group compares (%)
Group n Obviously absorb Absorb Constant Worsen
Treatment group 180 132(73.3) 35(19.4) 13(7.2) 0(0)
Matched group 100 35(35) 27(27) 25(25) 13(13)
The closed situation in cavity relatively
Empty closed situation relatively sees Table 5 in treatment group and the matched group lung
Empty closed situation compares (%) in table 5 treatment group and the matched group lung
Group n Closed Dwindle Constant Increase
Treatment group 180 151(83.9) 22(12.2) 7(3.9) 0(0)
Matched group 100 39(39) 23(23) 28(28) 10(10)
Model case
The man, 37 years old, the peasant, Maoming City people from suburb suffered from the pulmonary tuberculosis medical history 18 years because irregular treatment, spitting of blood repeatedly, because of fatigue afterwards suddenly massive hemoptysis enter hospitalize after 1 hour.Have a medical check-up: T37.5 ℃, R26 time/minute, P100 time/minute, BP100/72mmHg (13.3/9.5Kpa), refreshing clear, spiritual poor, the expendable sickly complexion, two pulmonary respiration sounds are thick, audible and be dispersed in rale.Rabat shows: two lung infiltrative pulmonary tuberculosises; Expectorant bacterium (+).Diagnosis: pulmonary tuberculosis merges massive hemoptysis.The processing of being admitted to hospital: absolute bed rest gives the measures such as antiinflammatory, anti-consumptive disease, hemostasis, blood transfusion 400mL supporting treatment.7 days spitting of bloods of above Regimen Chemotherapy are more than, expectoration is with the blood streak, chest pain, massive hemoptysis 1 time appearred in 3 ~ 5 days in patient, powder 2 treatments with the present invention's preparation, first dose take after, second day spitting of blood is namely ended, take 5 doses after bloody sputum, chest pain disappear, the project specification treatment is implemented in the rear continuation of leaving hospital, and follows up a case by regular visits to have no the generation of spitting of blood phenomenon in 1 year.
This intellectual property of primary enforcement that all are above-mentioned is not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above only is preferred embodiment of the present invention, is not to be the restriction of the present invention being made other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not break away to any simple modification, equivalent variations and remodeling that above embodiment does, still belongs to the protection domain of technical solution of the present invention according to technical spirit of the present invention.

Claims (11)

1. novel Chinese medicine composition that is used for the treatment of drug-tolerant pulmonary tuberculosis, it is characterized in that, comprising: the Radix Astragali, Radix Ranunculi Ternati, Semen Lablab Album, Caulis Polygoni Multiflori, Radix Morindae Officinalis, Herba Ecliptae, Semen Arecae, the Radix Stemonae, the Radix Pulsatillae, Rhizoma Belamcandae, the Rhizoma Anemarrhenae, Radix Semiaquilegiae, Semen Myristicae, Exocarpium Citri Grandis, Radix Asteris, Rhizoma Alpiniae Officinarum, Herba Orostachyos, Flos Carthami, Radix Salviae Miltiorrhizae, Cacumen Platycladi, Herba Leonuri.
2. Chinese medicine composition as claimed in claim 1 is characterized in that:
The weight fraction of each component ratio is in the described Chinese medicine composition,
The Radix Astragali 62 ~ 72 weight portions, Radix Ranunculi Ternati 48 ~ 58 weight portions, Semen Lablab Album 36 ~ 46 weight portions, Caulis Polygoni Multiflori 27 ~ 37 weight portions, Radix Morindae Officinalis 31 ~ 41 weight portions, Herba Ecliptae 16 ~ 26 weight portions, Semen Arecae 8 ~ 18 weight portions, the Radix Stemonae 24 ~ 34 weight portions, the Radix Pulsatillae 37 ~ 47 weight portions, Rhizoma Belamcandae 23 ~ 33 weight portions, the Rhizoma Anemarrhenae 32 ~ 42 weight portions, Radix Semiaquilegiae 12 ~ 22 weight portions, Semen Myristicae 18 ~ 28 weight portions, Exocarpium Citri Grandis 21 ~ 31 weight portions, Radix Asteris 14 ~ 24 weight portions, Rhizoma Alpiniae Officinarum 17 ~ 27 weight portions, Herba Orostachyos 22 ~ 32 weight portions, Flos Carthami 26 ~ 36 weight portions, Radix Salviae Miltiorrhizae 30 ~ 40 weight portions, Cacumen Platycladi 16 ~ 26 weight portions, Herba Leonuri 21 ~ 31 weight portions.
3. Chinese medicine composition as claimed in claim 1 is characterized in that:
The ratio of weight and number of each component is in the described Chinese medicine composition, the Radix Astragali 67 ~ 72 weight portions, Radix Ranunculi Ternati 53 ~ 58 weight portions, Semen Lablab Album 41 ~ 46 weight portions, Caulis Polygoni Multiflori 32 ~ 37 weight portions, Radix Morindae Officinalis 36 ~ 41 weight portions, Herba Ecliptae 21 ~ 26 weight portions, Semen Arecae 13 ~ 18 weight portions, the Radix Stemonae 29 ~ 34 weight portions, the Radix Pulsatillae 42 ~ 47 weight portions, Rhizoma Belamcandae 28 ~ 33 weight portions, the Rhizoma Anemarrhenae 37 ~ 42 weight portions, Radix Semiaquilegiae 17 ~ 22 weight portions, Semen Myristicae 23 ~ 28 weight portions, Exocarpium Citri Grandis 26 ~ 31 weight portions, Radix Asteris 19 ~ 24 weight portions, Rhizoma Alpiniae Officinarum 22 ~ 27 weight portions, Herba Orostachyos 27 ~ 32 weight portions, Flos Carthami 31 ~ 36 weight portions, Radix Salviae Miltiorrhizae 35 ~ 40 weight portions, Cacumen Platycladi 21 ~ 26 weight portions, Herba Leonuri 26 ~ 31 weight portions.
4. Chinese medicine composition as claimed in claim 1 is characterized in that:
Can further add Cordyceps and Fructus Schisandrae Chinensis in described Chinese medicine composition, described Cordyceps and the addition of described Fructus Schisandrae Chinensis in described Chinese medicine composition are Cordyceps 17 ~ 27 weight portions and Fructus Schisandrae Chinensis 12 ~ 22 weight portions.
5. Chinese medicine composition as claimed in claim 1 is characterized in that:
Can further add Radix Curcumae and Rhizoma Corydalis in described Chinese medicine composition, described Radix Curcumae and the addition of described Rhizoma Corydalis in described Chinese medicine composition are Radix Curcumae 21 ~ 31 weight portions and Rhizoma Corydalis 10 ~ 20 weight portions.
6. Chinese medicine composition as claimed in claim 1, it is characterized in that: described Chinese medicine composition is prepared into powder, oral liquid, tablet, capsule.
7. the preparation method of Chinese medicine composition claimed in claim 1 is characterized in that, may further comprise the steps:
The first step, described component is mixed in proportion, is placed in the super micron mill and pulverized 20 minutes～40 minutes, it is in 80%～90% the ethanol that the mixture after pulverizing is dissolved in determining alcohol, reflux, extract, 2 times～4 times, filter, merging filtrate, concentrating under reduced pressure is removed ethanol, obtain dried mastic, wherein, the amount of the ethanol of adding is 2～4 times of first step mixture quality, carries out subsequently drying, pulverized 20 minutes～40 minutes with super micron mill, powder after pulverizing is added water dissolution with respect to 3～5 times of amounts of its quality, stir lower the adding with respect to powder quality 10%～15% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, adding concentration and be 10% sulphuric acid, to regulate pH value be 3～4, static 2～4 hours, filters, filtrate is used alcohol extraction, the extract concentrating under reduced pressure becomes dried mastic, and subsequent drying is ground into 50 orders～100 purpose fine powders;
Second step according to needed dosage form, adds conventional auxiliary element, prepares needed pharmaceutical composition.
8. the preparation method of Chinese medicine composition as claimed in claim 1, it is characterized in that: when the dosage form of described pharmaceutical composition is tablet, described second step is specially, add excipient and granulate in the powder of above-mentioned acquisition, drying adds disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or film coating namely obtains tablet.
9. the preparation method of Chinese medicine composition as claimed in claim 1, it is characterized in that: when the dosage form of described pharmaceutical composition was oral liquid, described second step was specially, and added the distilled water with respect to 3～5 times of amounts of its quality in the powder that the first step obtains, 0.1～0.3 times sucrose, 0.01～0.02 times sodium benzoate stirs, and boils, cooling, filter, packing, sterilization namely obtains oral liquid.
10. the preparation method of Chinese medicine composition as claimed in claim 1, it is characterized in that: when the dosage form of described pharmaceutical composition is powder, described second step is specially, and adds the starch mix homogeneously with respect to 1～3 times of its quality in the powder that the first step obtains, and is prepared into powder.
11. the Chinese medicine composition described in the claim 1 to 5 for the preparation of the treatment drug-tolerant pulmonary tuberculosis medicine in application.
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CN108424771A (en) * 2018-04-27 2018-08-21 湖南口味王集团有限责任公司 A kind of betelnut extract of good in oxidation resistance
CN114159533A (en) * 2021-12-28 2022-03-11 上海中医药大学附属龙华医院 Traditional Chinese medicine composition for treating multiple drug-resistant bacterial infection and application thereof

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